DENVER, Colo., Nov 11, 2025 (247marketnews.com)- Here’s what’s setting the tone before the bell
enGene Holdings Inc. (NASDAQ:ENGN) surged in premarket trading after unveiling new preliminary data from its Phase 2 LEGEND trial for detalimogene voraplasmid in high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The candidate showed a 62% complete response rate at six months under the amended trial protocol, with low treatment-related adverse events (42%) and minimal dose interruptions (1.6%).
The company exceeded its enrollment target with 125 patients, strengthening confidence in its upcoming BLA submission in the second half of 2026. The updated FDA discussions shifted the trial’s primary endpoint to “complete response at any time,” aligning it with contemporary regulatory expectations for NMIBC therapies.
Chief Medical Officer Dr. Hussein Sweiti noted the improved response data supports detalimogene’s “potential for best-in-class tolerability and ease of use,” while CEO Ron Cooper reaffirmed plans to move toward commercial readiness. ENGN’s conference call at 8:00 a.m. ET is expected to draw close scrutiny from biotech analysts as the company positions for what could be one of the most closely watched bladder cancer programs of 2026.
VENU (NYSE:VENU) continues to prove its “build, own, and earn” model, reporting a $6.2 million development profit on the $14 million sale-leaseback of its Colorado Springs parking property supporting the Ford Amphitheater. The deal allowed VENU to retain operational control and preserve a buyback option, underscoring CEO J.W. Roth’s “intentional” approach to real estate monetization.
Meanwhile, attention is shifting to VENU’s Sunset Amphitheater project in Broken Arrow, Oklahoma, which includes a multi-event incentive agreement with Live Nation (NYSE: LYV). The partnership gives Live Nation booking rights while allowing VENU to maintain strategic flexibility, a notable move as VENU expands its Luxe FireSuites concept and scales its zero-debt, recurring-revenue model.
Nebius (NASDAQ:NBIS) delivered a one-two punch this morning: third-quarter financial results and a blockbuster $3 billion, five-year AI infrastructure deal with Meta Platforms (NASDAQ:META). The agreement solidifies Nebius as a serious global contender in the high-performance computing (HPC) and cloud infrastructure market.
The company also unveiled plans for an at-the-market (ATM) equity program of up to 25 million Class A shares, enabling flexible funding for growth. Founder and CEO Arkady Volozh’s shareholder letter, published this morning, emphasizes Nebius’ disciplined capital strategy amid surging demand for AI compute power.
Clean-tech innovator Turbo Energy (NASDAQ:TURB) announced a strategic partnership with Taurus S.A. and the Stellar Development Foundation to tokenize hybrid renewable energy financing, debuting with a supermarket pilot project in Spain. The initiative leverages Turbo’s SUNBOX solar storage systems and Taurus’ institutional-grade blockchain platform to enable fractionalized, on-chain financing of clean energy infrastructure.
CEO Mariano Soria said the effort creates “a pathway for new revenue streams and wider access to sustainable investments,” while Stellar’s Denelle Dixon described it as “real-world blockchain innovation serving the global energy transition.” The project taps into a $74.4 billion Energy-as-a-Service (EaaS) market, projected to nearly double by 2030, according to Grand View Research.
BigBear.ai (NYSE:BBAI) shares are on radar after announcing third-quarter 2025 results alongside a definitive $250 million agreement to acquire Ask Sage, a secure generative AI platform used across defense and national security agencies. Ask Sage serves over 100,000 users on 16,000 government teams, bringing scalable agentic AI capabilities directly into BigBear.ai’s mission-critical ecosystem.
CEO Kevin McAleenan called the acquisition “what the market has been asking for: a secure, integrated AI platform that connects software, data, and mission services in one place.” BigBear ended the quarter with record cash of $456.6 million and continues to guide for full-year 2025 revenue between $125 million and $140 million.
Despite year-over-year revenue softness due to Army program delays, the company’s $376 million backlog and expansion into federal AI systems signal durable long-term demand, particularly as U.S. defense budgets tilt toward autonomous intelligence and cybersecurity.
Quoin Pharmaceuticals (NASDAQ:QNRX) successfully achieved target loading concentrations for two proprietary topical rapamycin delivery technologies. The company reported rapamycin loadings of 4% w/w for its topical lotion and 5% w/w for its dermal patch system, a milestone that positions Quoin to begin clinical trial and stability batch manufacturing in the fourth quarter of 2025.
Quoin expects clinical testing to begin in the first half of 2026 across several indications, including Microcystic Lymphatic Malformations and Venous Malformations, both of which currently have no FDA-approved treatments. The company believes the ability to achieve these high target loadings will provide competitive advantages in optimizing drug delivery at the site of disease compared to other topical formulations in development.
Chief Executive Officer Dr. Michael Myers called the development a “very significant milestone” for Quoin’s rapamycin programs, noting that the new delivery systems “could potentially provide competitive advantages over other topical rapamycin formulations.” He added that the programs are complementary to Quoin’s late-stage Netherton Syndrome and Peeling Skin Syndrome studies, which continue to progress following the company’s recent capital raise.
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